In May 2018, the U.S. Food and Drug Administration (FDA) strengthened its warnings to the public about the potentially life-threatening or lethal side effects that may occur with the use of benzocaine-containing products called methemoglobinemia.

Over-the-counter products containing benzocaine are used in an attempt to relieve teething discomfort in infants in spite of the FDA noting their lack of efficacy for this purpose. They are also used in an attempt to alleviate sore throats and canker sores as well as mouth, gum, and tooth pain in children and adults. (1) The FDA has received hundreds of reports of methemoglobinemia occurring in consumers after using oral benzocaine-containing products. (2)

What Is Methemoglobinemia?

Methemoglobinemia is a type of blood disorder in which higher-than-normal levels of methemoglobin are produced. When this condition occurs, affected red blood cells are unable to transport oxygen to tissues, and any oxygen present in the blood stream binds more tightly to unaffected red blood cells, and thus oxygen is not able to reach the body’s organs and tissues effectively. As the body’s tissues are deprived of oxygen, life-threatening complications or death can result. (3) (4)

Oral benzocaine products taken in an attempt to relieve mouth and gum pain may cause this dangerous medical condition. The FDA has issued safety warnings about over-the-counter oral products containing benzocaine and the risk of methemoglobinemia, noting that the FDA has received hundreds of adverse event reports regarding this problem. (5)

Specifically, the FDA is urging manufacturers to change warning labels to alert parents that they should not use benzocaine to treat their infants or children younger than two years of age. Products containing benzocaine pose life-threatening dangers to infants and offer no benefits for treating teething discomfort. The FDA is also warning consumers that methemoglobinemia can also occur in adults and older children using oral benzocaine-containing products. (6)

If you, your child, or another loved one developed methemoglobinemia after using a product containing benzocaine that resulted in hospitalization or death, we encourage you to contact us immediately.

An experienced Weitz & Luxenberg drug and medical device attorney can help you consider your legal options. Depending on your specific circumstances, you may be entitled to pursue compensation.

Benzocaine Can Cause Methemoglobinemia

Methemoglobinemia symptoms may include:

Pale, gray, or blue-tinted skin, lips, or nail beds (cyanosis).

Shortness of breath.

Fatigue.

Confusion.

Headache.

Lightheadedness.

Rapid heart rate (tachycardia).

It is possible for an adult, child, or infant to develop methemoglobinemia after using a product with benzocaine just once. This medical emergency can develop within minutes or up to several hours after using the product. (7)

If you, your child, or another loved one used a benzocaine product and had to be hospitalized or died after developing symptoms of methemoglobinemia, we urge you to contact us for a free-of-charge consultation.

You can reach us by phone at (800) 476-6070 or online by completing the form on this page. One of our representatives will contact you shortly.

What Is Benzocaine?

Some topical products containing benzocaine are intended to relieve discomfort due to scrapes and insect bites. As a local anesthetic, benzocaine can numb the skin temporarily. (8)

Benzocaine can block nerve pain signals. As oral numbing agents, benzocaine can be found as gels, liquids, sprays, and lozenges. (9)

What Are the Side Effects of Benzocaine?

There is a long list of potential side effects for benzocaine.

The Mayo Clinic lists these potential benzocaine side effefcts, which include, among others: (10)

Bluish color of the fingernails, lips, skin, palms, or nail beds.

Dark urine.

Difficulty breathing.

Difficulty walking.

Dizziness or lightheadedness.

Fainting.

Headache.

Numbness in the hands and feet.

Pale skin.

Rapid heart rate (tachycardia).

The Mayo Clinic also lists these other benzocaine side effects: (11)

Blistering, crusting, dryness, burning, or flaking of the skin.

Cracking, redness, itching, or stinging of the skin.

Itching, severe redness, scaling, soreness, or swelling of the skin.

Unusual bruising or bleeding.

Unusual dullness, tiredness, weakness, or sluggishness.

Fever.

Irritability.

Irritation of the nose.

Red, sore eyes.

Sore throat.

Benzocaine Side Effects Can Kill

Before purchasing products containing benzocaine, consider the possible side effects, such as potentially lethal methemoglobinemia. (12)

According to the FDA, methemoglobinemia is a dangerous condition that results from “elevated levels of methemoglobin in the blood and it can lead to death. It causes the amount of oxygen carried through the blood to be greatly reduced.” (13)

If you, your child, or another loved one used a benzocaine-containing product and developed methemoglobinemia that resulted in hospitalization or death, you may be able to pursue compensation from the manufacturer.

Hiring an attorney with experience in handling lawsuits due to the side effects of defective drugs may be something you want to consider. We encourage you to contact Weitz & Luxenberg for a free initial consultation. Our attorneys have the knowledge and understanding to help you evaluate your legal options.

Benzocaine and Mouth and Gum Pain

The FDA is warning the public about using over-the-counter benzocaine products to alleviate teething pain in infants. The agency has concluded these products pose a significant risk to the public, especially infants and children. (14)

The FDA has asked companies to stop marketing these products as pain relievers for teething, noting their lack of efficacy for this purpose. The agency has also advised companies to use stronger warning labels on oral products containing benzocaine, warning of the potential for methemoglobinemia to occur with use. (15) (16)

Benzocaine Sprays

Benzocaine sprays have been used as an oral anesthetic prior to performing upper endoscopy procedures in patients. One brand of topical 20 percent benzocaine spray commonly used is called HurriCaine. (17) (18) (19) (20) (21) (22) (23) (24)

For years, the FDA has been receiving reports of benzocaine sprays linked to this potentially life-threatening medical condition. (33)

The FDA issued a Public Health Advisory in 2006, and a Safety Announcement in 2011, warning the public of the potential for methemoglobinemia to occur with the use of benzocaine sprays. The U.S. Veterans Health Administration announced it would be discontinuing use of benzocaine sprays for medical procedures involving numbing of mucous membranes of the mouth and throat in 2006 due to the potential for these products to cause methemoglobinemia. (34)

Benzocaine Gel

Topical benzocaine gel has been used to relieve toothaches. However, in 2011, and again in 2018, the FDA issued safety warnings about using over-the-counter benzocaine gels, liquids, sprays, ointments, solutions, and lozenges to relieve mouth and gum pain. (35)

The agency said these products can cause the potentially severe medical condition methemoglobinemia. In extremely severe cases, methemoglobinemia can lead to death. (36)

Baby Orajel

In 2012, the FDA concluded that babies and benzocaine were not a good mix. Baby Orajel and other over-the-counter products containing benzocaine marketed as teething remedies can be dangerous, and in rare cases, fatal. (37)

In fact, the agency concluded Baby Orajel and other over-the-counter benzocaine products marketed for teething pain can on occasions lead to serious —and sometimes fatal — methemoglobinemia. For this reason, the FDA recommends that parents and caregivers not use benzocaine products in children younger than two. (38)

The FDA again warned against the use of these products in 2018, and strongly urged manufacturers to include a contraindication against use for teething and against use in children or infants younger than two. The FDA warned that if manufacturers of these products did not comply, the FDA would “take action to remove these products from the market.” (39)

Orajel for Babies

The Mayo Clinic has also advised parents not to use benzocaine-containing products marketed to relieve teething pain. Parents may be tempted to use Orajel for babies or other oral benzocaine-containing products when young ones are teething based on claims made for teething pain relief in product marketing or packaging, but the Mayo Clinic offers other remedies, such as: (40)

Rubbing your baby’s gums with a clean finger or moistened gauze pad. The pressure can help ease pain.

Allowing your infant to suck on a cold washcloth, spoon, or chilled teething ring. It’s important to remember not give your babies anything they could choke on, however, and the Mayo Clinic also warns against giving babies frozen teething rings.

Giving your infant hard foods for gnawing, such as peeled and chilled cucumbers or carrots if they are able to eat solid foods. Again, it is important to not give babies something they could choke on, however.

Drying the drool. Although heavy drooling is part of the teething process, drying drool can prevent skin irritation, as can applying water-based creams or lotions.

Baby Orajel Danger

The FDA says Baby Orajel danger and other benzocaine-containing product danger is very real. Parents may think Baby Orajel and other benzocaine-containing products could help the discomfort of their teething infants, but this belief is not supported by scientific evidence and use of these products instead can cause serious, life-threatening or fatal harm. (41)

Baby Orajel danger and other oral benzocaine-containing product danger is to be taken very seriously. Infants can die from Baby Orajel and other benzocaine-containing products. (42)

According to the FDA, oral products marketed for teething pain containing benzocaine are not helpful. While teething, babies drool. When parents apply a teething medication on their baby’s gums, the medication simply washes out of the mouth. (43)

Instead, the FDA recommends parents should try other remedies to ease their infant’s teething discomfort. Examples include massaging gums or giving babies something cold to gnaw on. In all instances, parents should supervise their infants to make sure the infant is safe and not at risk of choking, however. (44)

Get Help If You’re Dealing with Benzocaine-Induced Methemoglobinemia Complications

If you, your child, or another loved one experienced methemoglobinemia due to a product containing benzocaine and required hospitalization or died from this condition, we encourage you to contact an experienced attorney. We can help you regarding your potential benzocaine-induced methemoglobinemia lawsuit.

At Weitz & Luxenberg, we have the knowledge and experience to assist you. Our attorneys are available across the country 24/7 to help our clients harmed by dangerous medications or products, including if you were harmed by benzocaine.

We are a national law firm with a proven history of securing deserved compensation on behalf of our clients. Weitz & Luxenberg attorneys have been representing people injured by defective medications for more than 30 years.

Our experienced attorneys have won billions of dollars in settlements and verdicts on behalf of thousands of clients. Our attorneys are prepared to provide you with the guidance you need regarding your legal options.

U.S. Food & Drug Administration. (2011, April 7). FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm250040.htm

U.S. Food & Drug Administration. (2011, April 7). Drugs. FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm250024.htm